K891993 is an FDA 510(k) clearance for the COLLAGEN NEUROSPONGE. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on March 23, 1990, 360 days after receiving the submission on March 28, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K891993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1989 |
| Decision Date | March 23, 1990 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |